Commissioning & Qualification - Pharmaceutical sector

AKKODIS Belgium is looking for an experienced person in a pharmaceutical environment in the field of Commissioning & Qualification.

Tasks

• Act as C&Q to provide guidance and to manage suppliers and all C&Q activities for the systems, from design to field execution and to summary report approval.

• Draft, coordinate review and approval of C&Q documents (URS/ QRA/ SRA/ ERES/DQ/FAT/SAT/IQ/OQ/ VP..).

• Generate and review Change Controls related to C&Q.

• Drive verification testing, protocol execution, walk-downs, verification of system drawings and troubleshoot as required.

• Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected systems.

• Conduct deviation investigation and resolution, take appropriate corrective actions as required.

• Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected systems.

• Ensure Start-up of equipment/ system is completed in a safe and coordinated manner.

Profile

• Bachelor or Master's degree in Engineering or in Life Sciences with relevant experience.

• Experience delivering Commissioning and Qualification for Pharmaceutical / Biotechnology projects.

• Knowledge of GxP.

• Understanding of a risk-based approach to C&Q.

• You are fluent in French and English.